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The biocompatibility of degradable magnesium interference screws: an experimental study with sheep.

ABSTRACT: Screws for ligament reconstruction are nowadays mostly made of poly-L-lactide (PLLA). However, magnesium-based biomaterials are gathering increased interest in this research field because of their good mechanical property and osteoanabolic influence on bone metabolism. The aim of this pilot study was to evaluate the biocompatibility of an interference screw for ligament reconstruction made of magnesium alloy W4 by diecasting and milling and using different PEO-coatings with calcium phosphates. PLLA and titanium screws were used as control samples. The screws were implanted in the femur condyle of the hind leg of a merino sheep. The observation period was six and twelve weeks and one year. Histomorphometric, immunohistochemical, immunofluorescence, and molecular biological evaluation were conducted. Further TEM analysis was done. In all magnesium screws a clinically relevant gas formation in the vicinity of the biomaterial was observed. Except for the PLLA and titanium control samples, no screw was fully integrated in the surrounding bone tissue. Regarding the fabrication process, milling seems to produce less gas liberation and has a better influence on bone metabolism than diecasting. Coating by PEO with calcium phosphates could not reduce the initial gas liberation but rather reduced the bone metabolism in the vicinity of the biomaterial.

SUBMITTER: Thormann U

PROVIDER: S-EPMC4329844 | biostudies-literature | 2015

REPOSITORIES: biostudies-literature

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The biocompatibility of degradable magnesium interference screws: an experimental study with sheep.

Thormann Ulrich U Alt Volker V Heimann Lydia L Gasquere Cyrille C Heiss Christian C Szalay Gabor G Franke Jörg J Schnettler Reinhard R Lips Katrin Susanne KS

BioMed research international 20150131

Screws for ligament reconstruction are nowadays mostly made of poly-L-lactide (PLLA). However, magnesium-based biomaterials are gathering increased interest in this research field because of their good mechanical property and osteoanabolic influence on bone metabolism. The aim of this pilot study was to evaluate the biocompatibility of an interference screw for ligament reconstruction made of magnesium alloy W4 by diecasting and milling and using different PEO-coatings with calcium phosphates. P ...[more]

PMID: 25717474

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Project description:Purpose:To evaluate the long-term in vivo degradation of an amorphous stereoisomer combined with micro ?-tricalcium phosphate poly levo (96%)/dextro (4%) lactide beta-tricalcium phosphate biocomposite interference screw. Methods:A study approved by the institutional review board of in vivo biologic behavior of the screw was initiated in 2011 using an anterior cruciate ligament (ACL) reconstruction model. Twenty patients undergoing bone-patellar tendon-bone ACL reconstruction fixed at the femur and tibia with these biocomposite screws followed at least 36 months were evaluated by physical, radiographic, and computed tomography (CT) evaluations. Lysholm, Tegner, Cincinnati, and International Knee Documentation Committee scores were obtained. CT Hounsfield unit (HU) data were obtained at the femoral and tibial screw and other bone sites. An ossification quality score (range 1-4) was used to determine osteoconductivity at the screw sites. Results:In total, 11 male and 9 female patients evaluated by CT scan and radiographs a mean of 41 months postsurgery (range, 37-51) showed bone plug healing to the tunnel wall and the screw replaced with calcified and nontrabecular material. Osteoconductivity was present in 34 of 40 tunnels (85%) and nearly complete or complete (type 3 or 4 ossification) in 10 of 40 (25%). Mean screw-site densities (femoral 239 HU; tibial 290 HU) were consistent with cancellous bone density. One positive pivot-shift test was found. Lysholm, Cincinnati, Tegner, and International Knee Documentation Committee activity scores improved from 46.9, 43.5, 1.9, and 1.7 preoperatively to 92, 90.2, 6.0, and 3.2 at follow-up, respectively. The average postoperative Single Assessment Numeric Evaluation score was 86 and mean KT-1000 arthrometer difference was 0.32 mm. Conclusions:The micro ?-tricalcium phosphate poly levo (96%)/dextro (4%) lactide beta-tricalcium phosphate interference screw was replaced by calcified, nontrabecular material a mean of 42 months after implantation in a bone-patellar tendon-bone ACL reconstruction model. Osteoconductivity was confirmed. Level of Evidence:Level IV (therapeutic case series).

Project description:BackgroundScaphoid fractures are the most common carpal fractures. They often need to be treated by surgery, where the use of a compression screw is the globally accepted gold standard. Surgeons may choose between different implant materials including titanium alloys, which remain in the body or are removed after healing. An alternative are biodegradable magnesium-based implants. Properties of magnesium alloys include high stability, osteoconductivity, potential reduction of infections and few artifacts in magnetic resonance imaging (MRI). The aim of this trial is to demonstrate non-inferiority of magnesium-based compression screws compared with titanium Herbert screws for scaphoid fractures.MethodsThe trial is designed as a multicenter, blinded observer, randomized controlled parallel two-group post market trial. Approximately 190 patients will be randomized (1:1) with stratification by center either to titanium or magnesium-based compression screws. Follow-up is 1 year per patient. Surgical procedures and aftercare will be performed according to the German treatment guideline for scaphoid fractures. The first primary endpoint is the patient-rated wrist evaluation (PRWE) score after 6 months. The second primary endpoint is a composite safety endpoint including bone union until 6 months, no adverse device effect (ADE) during surgery or wound healing and no serious ADE or reoperation within 1 year. The third primary endpoint is the difference in change MRI artifacts over time. Non-inferiority will be investigated for primary endpoints 1 (t-test confidence interval) and 2 (Wilson's score interval) using both the full analysis set (FAS) and the per protocol population at the one-sided 2.5% test-level. Superiority of magnesium over titanium screws will be established using the FAS at the two-sided 5% test-level (Welch test) only if non-inferiority has been established for both primary endpoints. Secondary endpoints include quality of life.DiscussionThis study will inform care providers whether biodegradable magnesium-based implants are non-inferior to standard titanium Herbert screws for the treatment of scaphoid fractures in terms of wrist function and safety. Furthermore, superiority of magnesium-based implants may be demonstrated using MRI, which is used as surrogate endpoint for screw degradation.Trial registrationDRKS, DRKS00013368 . Registered Dec 04, 2017.

Project description:Magnesium-based alloys are the most widely used materials for degradable metallic implants and have considerable potential for bone applications owing to their excellent stimulating effect on osteogenesis. However, their high corrosion rate limits their structural stability and causes oxygen deficiency and an excessive increase in the pH around the defect area during bone healing. Magnesium oxides, which are the main corrosion products of Mg, are nontoxic materials with useful effects on new bone formation and pH neutralization. Metal-phenolic networks were introduced recently as a cost-effective and efficient surface modifier and were fabricated by deposition of nanosized metal oxides on different types of substrates using the chemical reaction between phenolic groups and metallic ions. In this study, magnesium oxide films were formed successfully on a Mg-based substrate using Mg-phenolic networks. The effects of various coating parameters on the surface morphology, corrosion resistance, degradation behavior, wettability, and osteocompatibility of degradable metallic materials after surface modification with Mg-phenolic networks were thoroughly investigated for the first time. The results showed that the initial concentration of Mg ions was the main parameter affecting the corrosion resistance, which was almost as much as 3 times that of uncoated samples. Additionally, cytotoxicity and viability assessment and observation of the morphological changes in bonelike cells showed that the in vitro osteocompatibility was significantly enhanced by coatings with Mg concentrations of 2.4-3.6 mg mL-1. Finally, in vivo animal studies using the rat calvarial defect model confirmed that the proposed coating method mitigated the formation of gas cavities around the implantation area by reducing the corrosion rate of the Mg-based implant. The nanosized metal oxides produced by the Mg-phenolic network significantly improved the biodegradability and osteocompatibility of Mg alloys, suggesting a potential approach to advancing the clinical application of Mg alloys.

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The biocompatibility of degradable magnesium interference screws: an experimental study with sheep.

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The biocompatibility of degradable magnesium interference screws: an experimental study with sheep.

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